MALASEB- chlorhexidine gluconate and miconazole spray

Malaseb by

Drug Labeling and Warnings

Malaseb by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

For support of healthy skin for animals with conditions responsive to miconazole and/or chlorhexidine. Essential fatty acids and Vitamin E provides skin barrier support and hydration.

DESCRIPTION

Active Ingredients: 2% w/v Chlorhexidine Gluconate, USP; 1.74% w/v Miconazole, USP (equivalent to 2% w/v Miconazole Nitrate)

Also Contains: Propylene Glycol, SD Alcohol 3-C, Sodium Coco PG-Dimonium Chloride Phosphate, Acetic Acid, d-Alpha Tocopheryl Polyethylene Glycol Succinate, Linoleamidopropyl PG-Dimonium Chloride Phosphate

DOSAGE & ADMINISTRATION

Directions for Use: Use in a well-ventilated area. Spray directly onto the affected area(s) 2 - 3 times daily or as directed by your veterinarian. Do not allow animal to lick the treated areas until dry to prevent ingestion. All changes (positive or negative) in the condition of the skin and haircoat should be reported to your veterinarian to determine continued use of this spray.

PRECAUTIONS

Caution: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets.

SAFE HANDLING WARNING

Human Warning: Wash hands after use. Rare but serious allergic reactions have been reported with exposure to chlorhexidine gluconate.

STORAGE AND HANDLING

Store at room temperature. Protect from freezing. Keep away from extreme heat or flame.

SPL UNCLASSIFIED SECTION

Available through licensed veterinarians.

For Veterinary Use Only.

SPL UNCLASSIFIED SECTION

Manufactured for:
Dechra Veterinary Products
7015 College Blvd.
Overland Park, KS 66211
866.933.2472
www.dechra-us.com
Malaseb® is a registered
trademark of Dermcare-Vet Pty. Ltd.
MALSPRAY-8
REV05/22

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

SHAKE WELL BEFORE USING

Malaseb®
Spray
2% w/v Chlorhexidine
Gluconate, USP
2% w/v Miconazole Nitrate, USP
Formulated for dogs, cats
and horses
Antimicrobial, antifungal

8 fl. oz.
(236 mL)

Dechra

INGREDIENTS AND APPEARANCE

MALASEB 
chlorhexidine gluconate and miconazole spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17033-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
Miconazole Nitrate (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	Miconazole Nitrate	20 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-186-08	236 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/01/2022

Labeler - Dechra Veterinary Products (362142734)